FDA 510(k), K180259, Sterile Hypodermic Needle for Single Use
FDA 510(k), K180259, Sterile Hypodermic Needle for Single Use
510(K) Number: K180259
Device Name: Sterile Hypodermic Needle for Single Use
Manufacturer: Tina Cai
Device Classification Name: Needle, Hypodermic, Single Lumen
Regulation Number: FMI
Classification Product Code: KXA
Date Received: 01/30/2018
Decision Date: 05/18/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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Total pages: 612
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Fully redacted pages: 416
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Content pages: 196
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